FDA Releases 483 Reports for Infant Formula Manufacturer of Recalled Dried Powder Formula

FDA released its recent inspectional report (FDA 483 Inspectional Observations) dated 1/31-22 to 3/18-22 for Abbott Laboratories' Sturgis Michigan facility. This facity recently recalled baby formula after being linked to 4 infant deaths due to Cronobacter sakazakii. C. sakazakii is a bacterial hazard in baby formula because it can lead to severe infection in death in infants, especially those born prematurely.

From the CDC: "Cronobacter germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis). Infants 2 months of age and younger are most likely to develop meningitis if they get sick from Cronobacter. Other infants more likely to get sick are those born prematurely and those less able to fight germs and sickness because of illness or medical treatment, such as infants receiving chemotherapy for cancer."

A few items from the 483 Report

• FDA found C. sakazakii in the medium and high cares areas on Zone 2 and 3 samples, (with Zone 2 being surfaces adjacent to product contact surfaces and Zone 3 being further away such as floor samples).
• The firm also had positive environmental samples and finished product over a 2.5 year period.
• During inspection, there was a water leak issue in the dryer area, which is supposed to be a dry area. Water issues had been a long identified issue in the facility
• Product contact surfaces were not adequately protected from contamination. (Obs 2)
• Inadequate follow up on consumer complaints (Obs 3)
• Poor adherence to Personal Hygiene program for wearing protective gear (Obs 4) including people failing to sanitize designated work (captive) shoes as they move from area to area.

If you are unfamiliar with a 483 report and the type of issues noted on a report, you may want to check this out.

One thing that stands out is the lack of root cause analysis for issues experienced over time coupled with lax protocols.

More Food Importers Failing to Meet Regulatory Requirements for FSVP- March 22 Version

Over the past two weeks, FDA has issued Warning Letters to a half dozen food importers for not have the required FSVP in place for the items those companies were importing.

Euphrates Foods, LLC dba Labeeb Alani Inc. of Elk Grove Village, IL.did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a) for their imported food including Roasted white pumpkin seeds and nuts in-shell imported from (b)(4)  and Pistachio toffee imported from (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/euphrates-foods-llc-dba-labeeb-alani-inc-618723-12232021

FELLA GROUP LLC, of  Irvine, CA did not develop an FSVP for each of the following foods:  Mayocoba Beans imported from (b)(4)  Chick Peas (Garbanzo Beans) imported from (b)(4), Rustic Salad Dressing imported from (b)(4) and other imported foods

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fella-group-llc-625512-02252022

Keeler Family Farms of  Deming, NM.did not develop an FSVP for any foods imported, including whole, fresh onions imported from foreign suppliers, (b)(4), located in Chihuahua, Mexico.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/keeler-family-farms-624666-03022022

Global LC Inc DBA Rice Chicken, of San Diego, CA 9212  did not develop an FSVP for any of the  imported food, including  Batter mix imported from (b)(4) located in (b)(4) and b. Yang Neum sauce (Mild taste marinade) and roasted seasoning imported from (b)(4) located in (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-lc-inc-dba-rice-chicken-623004-02042022

SERGIO CARRANZA DBA MR CHESCOS, of Houston, Texas. did not develop an FSVP for any of the imported foods, including the following:

• Cola flavored carbonated soft drinks imported from foreign supplier (b)(4)

• Grape flavored carbonated soft drinks imported from foreign supplier (b)(4)

• Banana flavored carbonated soft drinks imported from foreign supplier (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sergio-carranza-dba-mr-chescos-619398-02032022

All Good Foods, Inc. of Industry, CA 91745-1814. did not develop, maintain, and follow an FSVP for any of the imported foods, including each the following food products:

Frozen Tiny Red Chili imported from your foreign supplier, (b)(4) in (b)(4)

Frozen Chopped Lemon Grass imported from your foreign supplier, (b)(4) in (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/all-good-foods-inc-624303-02072022

NY Firm Recalls All Fresh Cut Fruit and Vegetable Products and RTE Dips After Sampling Program Discovers Listeria On Equipment Surfaces

Fruit Fresh Up, Inc. is voluntarily recalling from the market all fresh cut fruit and vegetable products and ready to eat dips, as listed below, processed at its Depew, NY production facilities, due to a possible health risk from Listeria monocytogenes.  Products subject to the voluntary recall of fresh cut fruits and vegetables are packaged in clear plastic containers with a tamper evident seal and identified with a “Best if Used By” date between March 5, 2022, and March 23, 2022. Ready-to-eat dips are provided in 7oz clear plastic clamshell containers with a Best if Used By date of March 15, 2022 to March 31, 2022.  This voluntary recall notification is being issued after results from the environmental program found surfaces where products are packaged into containers to contain Listeria monocytogenes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fruit-fresh-inc-recalls-products-due-possible-health-risk
Fruit Fresh Up, Inc Recalls Products due to Possible Health Risk
Summary
Company Announcement Date:  March 20, 2022
FDA Publish Date:  March 20, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Fruit Fresh Up, Inc.
Brand Name:  

• Wegmans
• Fresh Harvest
• Lexington Co-op
• Tops

Product Description: Fresh cut fruit and vegetable products

CA Firm Recalls French Vanilla Yogurt After Mislabeling Issue Results in Undeclared Egg Allergen

St. Benoit Creamery of Sonoma, CA is recalling French Vanilla Yogurt, lot code # 2054, best by date 8/22/2022, because it may contain undeclared EGG allergen.  The recall was initiated after it was discovered that the Organic Desserts Pot De Crème Vanilla was mis-labeled as French Vanilla Yogurt and it did not reveal the presence of the EGG allergen.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/st-benoit-creamery-issues-allergy-alert-undeclared-egg-french-vanilla-yogurt
St. Benoit Creamery Issues Allergy Alert on Undeclared Egg in French Vanilla Yogurt
Summary
Company Announcement Date:  March 19, 2022
FDA Publish Date:  March 19, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg
Company Name:  St. Benoit Creamery
Brand Name:  St. Benoit Creamery
Product Description:  French Vanilla Yogurt

More Enoki Mushrooms Recalled Due to Listeria Risk

(Updated 3-22-22) Four companies are recalling enoki mushrooms due to Listeria.

Jan Fruits Inc. of VERNON, CA is recalling all its cases of its 200g/7.05oz packages of ENOKI MUSHROOM (Product of Taiwan) because it has the potential to be contaminated with Listeria monocytogenes. The recalled Enoki Mushroom product was distributed in CA to produce distributors or wholesalers for further distribution to retail stores.

T Fresh Company of City of Industry, CA is recalling its 5.25oz (150g) enoki mushrooms, Lot #6021053 grown in China & 7.5oz (200g) Lot # 6021052 grown in China, because it has the potential to be contaminated with listeria monocytogenes Lot #6021053 was distributed from California and Texas to retail stores through produce distributors.

Farm Fresh Produce LLC of Vernon, CA, is recalling all of the 14.11 ounce packages of "TWA AGRICULTURE MIXED MUSHROOMS" [which contain enoki mushrooms)

Top Quality Produce of Irwindale CA is recalling all cases of 200g/7.05oz package of Enoki Mushroom, product of Taiwan sold during 3/1/22-3/16/22 due to the Listeria contamination of Enoki mushrooms was discovered.

In all cases, the potential for contamination was discovered after a retail sample collected and analyzed by California Department of Public Health (CDPH) and revealed the presence of Listeria monocytogenes in 7.05 oz. package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jan-fruits-inc-recalls-enoki-mushrooms-because-possible-health-risk-0
Jan Fruits Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Summary
Company Announcement Date: March 18, 2022
FDA Publish Date: March 18, 2022
Product Type: Food & Beverages
Reason for Announcement: Listeria monocytogenes
Company Name: Jan Fruits, Inc.
Brand Name: Taiwan Best Quality
Product Description: Enoki Mushrooms

Gluten-Free Coconut Flour Tortillas Recalled After Wheat-containing Product in Packages

The Salsa Texan of Flower Mound, Texas is voluntarily recalling its regular and burrito sized packages of Coconut Flour Tortillas because they may contain undeclared wheat. The voluntary recall was initiated after it was discovered that the wheat containing product was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/salsa-texan-issues-allergy-alert-undeclared-wheat-contamination-gluten-free-coconut-flour-tortillas
The Salsa Texan Issues Allergy Alert on Undeclared Wheat Contamination in “Gluten Free Coconut Flour Tortillas”
Summary
Company Announcement Date:  March 18, 2022
FDA Publish Date:  March 18, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:   The Salsa Texan
Brand Name:  The Salsa Texan
Product Description:   Coconut Flour Tortillas

Pancake Mix Recalled After Fragments of Cable From Processing Line Found in Product

Continental Mills has issued a recall of Kroger Buttermilk Pancake & Waffle Mix, AND Walmart Great Value Buttermilk Pancake & Waffle Mix, UPC 078742370828, Lot code KX2063, Best By Date of 09/01/2023  due to a potential foreign material contamination. Fragments from a cable used to clear the processing line were discovered in a limited amount of product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/continental-mills-recalls-kroger-buttermilk-pancake-waffle-mix-due-possible-foreign-material
Continental Mills Recalls Kroger Buttermilk Pancake & Waffle Mix Due to Possible Foreign Material Contamination
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/continental-mills-recalls-kroger-Buttermilk-pancake-waffle-mix-due-possible-foreign-material
Summary
Company Announcement Date:  March 18, 2022
FDA Publish Date:  March 18, 2022
Product Type:   Food & Beverages
Reason for Announcement:  Potential foreign material contamination
Company Name:  Continental Mills
Brand Name:  Kroger
Product Description:  Buttermilk Pancake & Waffle Mix

Hash Browns Recalled for Undeclared Wheat After Supplier Labeling Issue

Cavendish Farms Corporation of Dieppe, New Brunswick, Canada, is recalling 441 cases of its 42.3 oz packages of Original Hash Brown Patties because they may contain undeclared wheat.   No confirmed illnesses have been reported to date in connection with this problem.  The recall was initiated after it was discovered the product contained wheat and was distributed in packaging that did not reveal the presence of wheat. Cavendish Farms was notified by a supplier that an ingredient it provided was mislabeled and did not identify the presence of wheat.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cavendish-farms-issues-allergy-alert-undeclared-wheat-original-hash-brown-patties
Cavendish Farms Issues Allergy Alert on Undeclared Wheat in Original Hash Brown Patties
Summary
Company Announcement Date:  March 17, 2022
FDA Publish Date:  March 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Cavendish Farms Corporation
Brand Name:  Cavendish Farms
Product Description:   Hash Brown Patties

Lancaster Farmer Fights the Courts on Food Safety Rules

There is an ongoing court action involving Lancaster, PA farmer Amos Miller as he tries to write his own rules for food safety.  Our good friend George Lapsley took the Justice Department's assignment for verifying that the Miller Organic Farm would adhere to the court order, but  Miller's refusal to work with George has landed Miller back in court.  Miller claims sovereign citizen rights, that is, that he has the right to set his own rules....but the court is not having any of it.   


https://lancasteronline.com/news/local/lancaster-farmer-agrees-again-to-follow-court-order-after-refusing-to-allow-food-safety-expert/article_dc563262-9feb-11ec-9847-eb35032cf6e9.html
Lancaster farmer agrees, again, to follow court order after refusing to allow food safety expert to inspect farm
DAN NEPHIN | Staff Writer Mar 10, 2022

A month ago, a federal judge appointed an expert to work with Upper Leacock farmer Amos Miller to make sure he complied with food safety laws and court orders — something he’s shown an unwillingness to do for years.